ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm) 2143

GUDID 00810008214527

ONE-CARE OPTI Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 00810008214527
• NIH Device Record Key: b92d1c81-d543-4e58-ae90-5954ba33d0e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5’’ (12.7mm)
• Version Model Number: ONE-CARE OPTI TB Safety Syringes 1ml x 28G x 0.5'’
• Catalog Number: 2143
• Company DUNS: 080740980
• Company Name: MediVena, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com

Device Dimensions

• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 28 Gauge
• Length: 0.5 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008214510 [Primary]
GS1	00810008214527 [Package]; Contains: 00810008214510; Package: Box [100 Units]; In Commercial Distribution
GS1	00810008214534 [Package]; Package: case [8 Units]; In Commercial Distribution

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-05
• Device Publish Date: 2024-02-26

Devices Manufactured by MediVena, LLC

• 00810008211540 - ONE-CARE Pen Needles,: 2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp
• 00810008211656 - ONE-CARE Pen Needles: 2025-03-20 he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a comp
• 00810008216385 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
• 00810008216408 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
• 00810008216422 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
• 00810008216446 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
• 00810008216460 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com
• 00810008217832 - GLUCO-CARE Pen Needles: 2025-03-20 The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a com